Shots:
- MHRA has approved Blenrep + BorDex & PomDex in MM pts with ≥1 prior therapy incl. Revlimid; review ongoing in 14 markets incl. US (PDUFA: Jul 23, 2025), EU, Canada, Japan [priority review (PR)], China (PR for DREAMM-7), & Switzerland (PR for DREAMM-8)
- Approval was based on P-III (DREAMM-7 & DREAMM-8) trials assessing Blenrep (2.5mg/kg, IV, Q3W) + BorDex vs Darzalex + BorDex in 494 pts & Blenrep + PomDex vs Velcade + PomDex in 302 pts, respectively
- DREAMM-7 met its 1EP of improved PFS (mPFS: 36.6 vs 13.4mos.), reducing death risk by 42% at 39.4mos. mFU & depicting a 3yr. OS rate of 74% vs 60%, while in DREAMM-8 (21.8mos. mFU), mPFS was not reached vs 12.7mos.; data was presented at ASCO 2024 & published in The NEJM
Ref: GSK | Image: GSK
Related News:- GSK Reports the US FDA’s BLA Acceptance of Blenrep (Belantamab Mafodotin) Regimen for Treating R/R Multiple Myeloma
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